The following data is part of a premarket notification filed by Delphi Consulting Group with the FDA for E-scope Electronic Stethoscope Model 718-7120.
Device ID | K961301 |
510k Number | K961301 |
Device Name: | E-SCOPE ELECTRONIC STETHOSCOPE MODEL 718-7120 |
Classification | Stethoscope, Electronic |
Applicant | DELPHI CONSULTING GROUP 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
Contact | J. Harvey Knauss |
Correspondent | J. Harvey Knauss DELPHI CONSULTING GROUP 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
Product Code | DQD |
CFR Regulation Number | 870.1875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-04-04 |
Decision Date | 1996-06-11 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B37871877100 | K961301 | 000 |
B37571877000 | K961301 | 000 |